Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003328
Status:
COMPLETED
Last Update Posted:
2010-05-21
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Porfiromycin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
Boehringer Ingelheim
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Double-Blind Randomised Placebo-Controlled Study of Porfiromycin When Used as an Adjuvant to Radiation Therapy in Patients With Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2010-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether radiation therapy followed by porfiromycin is more effective than radiation therapy alone in treating patients with head and neck cancer
PURPOSE Randomized double-blinded phase III trial to determine the effectiveness of radiation therapy followed by porfiromycin in treating patients with stage III or stage IV head and neck cancer
PURPOSE Randomized double-blinded phase III trial to determine the effectiveness of radiation therapy followed by porfiromycin in treating patients with stage III or stage IV head and neck cancer
Detailed Description:
OBJECTIVES I Determine the time to tumor progression in patients with stage III or IV without distant metastases head and neck cancer treated with porfiromycin as adjuvant therapy to radiotherapy II Determine percentage of patients with locoregional tumor recurrence up to 2 years posttreatment III Determine response rate disease free survival time and overall survival time in these patients IV Evaluate the safety and tolerance of porfiromycin in these patients
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to primary tumor site oral vs pharynx vs larynx and disease stage both T and N stage T1-2 vs T3-4 and N0 vs N1-2 vs N3 All patients are randomized to receive either porfiromycin arm I or placebo arm II as adjuvant therapy to radiation therapy Both arms follow the same treatment schedule Daily radiation therapy commences on day 1 Patients receive porfiromycin or placebo by intravenous infusion over 30-60 minutes on day 5 and then on day 46 or 47 Porfiromycin or placebo is administered 30 minutes to 2 hours following radiation therapy All patients with N3 neck disease metastases in a lymph node more than 6 cm in greatest dimension undergo a planned neck dissection following external beam radiation at 4 to 12 weeks following therapy This surgery is not needed for patients with N3 neck disease who do not have residual disease following radiotherapy Patients are followed at 4 weeks then every 2 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 550-600 patients will be accrued for this study within 3 years
OUTLINE This is a randomized double blind placebo controlled multicenter study Patients are stratified according to primary tumor site oral vs pharynx vs larynx and disease stage both T and N stage T1-2 vs T3-4 and N0 vs N1-2 vs N3 All patients are randomized to receive either porfiromycin arm I or placebo arm II as adjuvant therapy to radiation therapy Both arms follow the same treatment schedule Daily radiation therapy commences on day 1 Patients receive porfiromycin or placebo by intravenous infusion over 30-60 minutes on day 5 and then on day 46 or 47 Porfiromycin or placebo is administered 30 minutes to 2 hours following radiation therapy All patients with N3 neck disease metastases in a lymph node more than 6 cm in greatest dimension undergo a planned neck dissection following external beam radiation at 4 to 12 weeks following therapy This surgery is not needed for patients with N3 neck disease who do not have residual disease following radiotherapy Patients are followed at 4 weeks then every 2 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 550-600 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V98-1416 | None | None | None |
| BOEH-PORF-96-001 | None | None | None |
| BOEH-BI-11641 | None | None | None |
| COVANCE-1403 | None | None | None |
| VION-PORF-96-001 | None | None | None |